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Linaclotide for Chronic Constipation in Type 2 Diabetes
Study Summary
This trial has two phases. In the first phase, patients are randomly assigned to receive either the active drug or a placebo for 14 days. In the second phase, the order is reversed. There is a 2-week break in between phases during which patients do not receive any medication. The trial is closely monitored for safety.
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Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I regularly take NSAIDs more than three times a week.I do not have any severe illnesses that my doctor thinks should keep me out of the study.I haven't used laxatives (except fiber) 3 days before joining, and won't use them often during the trial.I struggle significantly with bowel movements due to pelvic floor issues.I have type II diabetes.I have been constipated for at least 6 months.I've had loose or watery stools for more than 25% of the time without taking laxatives.I have not taken drugs like domperidone, opiates, or anti-spasmodics in the last 3 days.I do not use illegal drugs.I drink more than 2 alcoholic beverages daily.I have or had severe diverticulitis and hemorrhoids.I have had constipation for over 6 months with hard stools and often feel incomplete after going.Your hemoglobin A1c level is higher than 8.2.I have had surgery on my stomach or part of my colon removed.You have frequent hard or lumpy stools, based on a specific scale used to describe stool appearance.I have severe gastroparesis, need tube feeding, often hospitalized, or have a gastric neurostimulator.I have fewer than three bowel movements per week.I have diabetic nerve pain or stomach issues like GERD.I have been diagnosed with functional constipation.You have been diagnosed with Diabetic Autonomic Neuropathy using the ANX 3.0 real-time ANS monitoring system.
- Group 1: 1)28days of linaclotide or placebo
- Group 2: 2)28days of linaclotide or placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the aggregate size of this medical experiment?
"At the present moment, this clinical trial is not accepting applicants. Initially posted on September 1st 2015 and most recently updated April 8th 2022, interested parties can look to other trials for diabetes mellitus which have 1242 studies currently active in search of participants with 4 actively enrolling."
Is the patient pool of this trial open to individuals aged 45 and up?
"This trial is seeking patients between 18 and 70 years of age. For those under the legal consenting age, there are 206 trials available; conversely, 930 studies cater to individuals above 65 years old."
Does this clinical research currently need participants?
"This study is no longer open to participant enrolment. It was first published on September 1st 2015 and last updated on April 8th 2022. If you are looking for other trials, 1242 studies related to diabetes mellitus are currently recruiting patients and 4 clinical trials offering this particular treatment remain active."
Do I meet the criteria to partake in this clinical exploration?
"In order to qualify for this medical trial, potential participants must have diabetes mellitus and be in the 18-70 year age range. The research program is looking to recruit approximately 23 patients."
Are there other research initiatives that have looked into this intervention?
"Presently, there exists 4 active clinical trials for this treatment with one trial in the third and final phase. While Philadelphia Pennsylvania is a major hub of research activity, 146 other locations are conducting studies related to this medication."
Has this medication been certified by the FDA?
"The safety of the treatment was rated a 3 due to this being a Phase 4 trial, which denotes that it has already been approved for use."
Who else is applying?
What portion of applicants met pre-screening criteria?
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